Empagliflozin and Metformin Hydrochloride Tablets 12.5/500 mg

Adult dose

The recommended dosage of this medication is 1 tablet per dose, taken twice a day. Each patient’s current treatment regimen, efficacy, and tolerance must be considered, adhering to the maximum recommended daily doses of empagliflozin 25 mg and metformin 2000 mg. If blood sugar control is insufficient with monotherapy with metformin or in combination with other medications like insulin, the recommended dosage for empagliflozin is 5 mg taken twice daily (total daily dosage of 10 mg).

This medication can cause a rare but serious metabolic complication known as severe lactic acidosis, so patients with impaired kidney function or those with respiratory disease, sepsis, etc. should exercise caution. Additionally, when used in combination with insulin or sulfonylurea drugs, the risk of severe hypoglycemia may increase, so dose adjustments may be necessary to reduce the risk of hypoglycemia. This medication should not be administered to patients with moderate or severe renal impairment or in situations where acute kidney injury is suspected, and it should also be temporarily discontinued before and after surgery or radiologic examination requiring contrast agents. It is advisable not to use this medication during pregnancy or breastfeeding. This drug may increase the risk of urinary tract infections or genital infections, and if symptoms of infection occur, immediate consultation with healthcare professionals is recommended. Fluid loss may occur during treatment, so caution should be exercised if there are signs of dehydration or hypotension, especially in elderly patients or those with cardiovascular diseases. Long-term use may lead to vitamin B12 deficiency, therefore regular blood testing is recommended. Alcohol consumption may increase the risk of lactic acidosis, so excessive drinking should be avoided during treatment. Some blood sugar monitoring methods may not be appropriate for accurately assessing blood sugar control while taking this medication, so blood sugar should be monitored as directed by healthcare professionals. This medication is not recommended for children under 18 years of age, and in elderly patients, dose adjustments should be made while regularly monitoring renal function. In case of overdose, individuals should seek medical attention immediately, and in severe cases, dialysis may be required. Finally, this medication should be kept out of the reach of children and stored in its original container.

Serious side effects

Urticaria, angioedema, severe swelling (edema), lactic acidosis, ketoacidosis, perineal necrosis, urosepsis, pyelonephritis, severe skin reactions (severe rash with fever, blisters, peeling skin, oral/ocular mucosal pain), liver dysfunction (jaundice), urticaria, angioedema, perineal necrosis, severe edema, difficulty breathing, asthma attacks, hepatitis, interstitial nephritis, severe lactic acidosis, myocardial infarction, cerebral infarction, severe

Mild side effects

• Hypoglycemia
• urinary tract infection
• genital infection
• increased urination
• nausea
• vomiting
• diarrhea
• abdominal pain
• loss of appetite
• constipation

This medication should be kept in a sealed container to protect it from air and moisture, and it is recommended to store it at room temperature between 1°C and 30°C. Proper storage will help maintain the efficacy of the medication.

Appearance

Pale brownish purple, oval, biconvex film-coated tablets

Package unit

10 tablets/box [(10 tablets/PTP X 1)], 60 tablets/box [(10 tablets/PTP X 6)], 60 tablets/bottle